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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: BWF FDA class 2

    Spirometer, Therapeutic (Incentive)

    Anesthesiology

    View full classification →

    The Spirometer, Therapeutic (Incentive) is a device used to encourage patients to take slow, deep breaths to expand the lungs and prevent postoperative pulmonary complications such as atelectasis. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BWF, regulated under 21 CFR 868.5690 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AllPEP
    LungTrainer (MD2 & MD3)
    Breathe+
    Hudson RCI Triflo II Incentive Deep Breathing Exerciser
    Pulsehaler
    D R Burton OxyPAP
    Acapella Choice Blue Vibratory PEP Device
    Combined Aerobika OPEP and VersaPAP device
    Hudson RCI Voldyne Volumetric Exerciser
    VersaPAP Positive Airway Pressure (PAP) Device
    VPOD ITPR
    MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
    VibraPEP
    iPEP System and vPEP
    O-PEP
    VibraPEP
    Aerobika OPEP Devive with Manometer
    AEROSURE MEDIC
    VOLUMETRIC INCENTIVE SPIROMETER
    TRIBALL INCENTIVE SPIROMETER
    AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
    LUNG FLUTE THERAPEUTIC
    PARI PEP S
    RESPIFIT S, MODEL RS-LR1001004
    CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
    SPIRO-BALL
    LIFESTYLE CIRCULATORY ENHANCER
    MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
    RESQPOD CIRCULATORY ENHANCER
    AEROPEP
    ACAPELLA
    CLINIFLO INCENTIVE SPIROMETER
    TRI-BALL
    INCENTIVE SPIROMETER
    FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
    ROADRUNNER, PEP THERAPY DEVICE
    BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
    RC CORNET, MODEL #44F50
    VITAL PEP
    THERAPEP
    MINI-CISER
    THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
    PARI PEP THERAPY SYSTEM
    DHD EMERALD PRODUCT
    MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
    THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
    PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
    MISTASSIST BREATHING EXERCISER
    THE BREATHER
    LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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